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Risk Assessment generated by a regulatory process
(RA)
last updated: 12 Sep 2017
risk assessment of genetically modified maize 5307 and Maize Bt11xMIR162xMIR604xTC1507x5307xGA21 - Technical Report 4764
EN
08 Oct 2015
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Competent National Authority:National Technical Biosafety Commission ()Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5516,Fax: (5561) 3317-7475,Email: ctnbio@mct.gov.br,Website: http://www.ctnbio.gov.br,
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Person:Dra Maria Sueli Felipe SoaresPresident,Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 08 à 10Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5151,Fax: (5561) 3317-7475,Email: msueliunb@gmail.com,Website: http://www.ctnbio.gov.br,Related OrganizationNational Technical Biosafety Comission (CTNBio)Government agency (National/Federal)Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 08 à 10Brasília, DF
CEP - 70610-200, BrazilPhone: (5561) 3411-5151,Fax: (5561) 3317-7475,Email: msueliunb@gmail.com,Website: http://www.ctnbio.gov.br,
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SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × DAS-Ø15Ø7-1 × SYN-Ø53Ø7-1 × MON-ØØØ21-9 - Agrisure® Duracade™ 5222| Syngenta Seeds GmbH | Resistance to diseases and pests (Insects, Coleoptera (beetles), Lepidoptera (butterflies and moths)), Resistance to herbicides (Glufosinate, Glyphosate)
- Parecer Final 4764Syngenta.pdf [ English ]
The history of safe use of Cry, Vip3, EPSPS, PAT and PMI proteins in plantations
which for some of these genes have been used for more than 19 years in several
countries, including Brazil, and based on data and evidence
the current scientific literature available for the proteins described in the application in
discussion, we consider that GM events are as safe as their equivalents
their food and environmental security
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which for some of these genes have been used for more than 19 years in several
countries, including Brazil, and based on data and evidence
the current scientific literature available for the proteins described in the application in
discussion, we consider that GM events are as safe as their equivalents
their food and environmental security
Microbial formulations of B. thuringiensis have been used for decades as
biopesticides in an organic production system or under conventional agricultural conditions,
to date, no impact on human, animal and environmental health has been related to the
their use. GM plants expressing Cry proteins have already been grown in several countries
for more than 19 years. The gene constructs requested in this process for commercial release
have already been released in Brazil (except for Milho 5307) and in several countries, both for consumption
cultivation, with no adverse effects on human, animal,
environment and non-target organisms. The overwhelming majority of the scientific literature on
health and environmental safety attests that there are no observable risks in the introduction of these
cultures containing Cry proteins.
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biopesticides in an organic production system or under conventional agricultural conditions,
to date, no impact on human, animal and environmental health has been related to the
their use. GM plants expressing Cry proteins have already been grown in several countries
for more than 19 years. The gene constructs requested in this process for commercial release
have already been released in Brazil (except for Milho 5307) and in several countries, both for consumption
cultivation, with no adverse effects on human, animal,
environment and non-target organisms. The overwhelming majority of the scientific literature on
health and environmental safety attests that there are no observable risks in the introduction of these
cultures containing Cry proteins.
All GM corn present in this commercial release proposal, classified as risk class 1, are as safe as their conventional equivalents, and not potentially cause significant degradation of the environment or health
human and animal. In the evaluations submitted to the CTNBio, criteria internationally accepted in the process of risk analysis of genetically and a set of evidences that demonstrated the safety for the cultivation of 5307, Bt11 x MIR162 x MIR604 x TC1507 x 5307 x GA21 and Bt11xMIR162.
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human and animal. In the evaluations submitted to the CTNBio, criteria internationally accepted in the process of risk analysis of genetically and a set of evidences that demonstrated the safety for the cultivation of 5307, Bt11 x MIR162 x MIR604 x TC1507 x 5307 x GA21 and Bt11xMIR162.
There is no difference between the agronomic performance of transgenic and conventional plants, as well as how there is substantial equivalence between them. Thus, information indicates that transgenic maize plants do not differ fundamentally from untransformed maize genotypes,
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In Brazil, there are no related species of maize in natural distribution.
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Maize (Zea mays) is not native to Brazil and there are no native, wild or feral species in the country that can interbreed with Zea mays. Therefore, there are no additional risks to the environment with the planting of maize 5307, Bt11xMIR162xMIR604xTC1507x5307xGA21 and Bt11xMIR162 in addition to those already caused for the different varieties of conventional maize in use in the country
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As established in art. 1 of Law 11,460, of March 21, 2007, "are prohibited the research and the cultivation of genetically modified organisms in the indigenous lands and areas of conservation units".
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Molecular Traditional Methods
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| Record type | Field | Record(s) | |
|---|---|---|---|
| Country's Decision or any other Communication | Risk assessment | 3 | |
